Marks, Michelle C.

Study Design Prospective Cohort Study. Objective The present study aims to determine if the racial representation of patients enrolled in a large prospective scoliosis registry is reflective of the general United States population. Further, we studied whether there was an association between race, pre-operative parameters, outcomes and loss to follow-up. Methods Prospectively collected data for patients who underwent spinal fusion for adolescent idiopathic scoliosis (AIS) was reviewed, including self-reported race/ethnicity. The U.S. pediatric population and U.S. patients enrolled in the prospective registry were compared. The data obtained was analyzed for variations between races, for pre-operative variables and follow-up. Results Of the 2210 included patients in the registry 66% of patients reported as White, while 52% of the 2018 U.S. pediatric population reported as White. 15% of the registry reported as Hispanic/Latino compared to 22% of the U.S. pediatric population, 13% Black compared to 14% of the U.S. pediatric population, and 4% Asian compared to 5% of the U.S. pediatric population. Asian and White patients had statistically significant higher 2-year follow-up in all but one of six enrollment sites ( P < 0.001). Native American, Other, and Hispanic/Latino patients had the highest BMIs. Native American and Black patients had the highest pre-op thoracic Cobb angles. Pre-op ages of Black, Hispanic, and Native American patients were statistically lower ( P < 0.01). Conclusion This study demonstrates the association between race and patient follow-up and pre-operative factors in patients who underwent surgery for AIS. Black, Native American, and Hispanic populations were underrepresented both at pre-op and follow-up when compared to their relative proportion in the U.S. pediatric population.

Background: Severe adolescent idiopathic scoliosis (AIS) can be treated with instrumented fusion, but the number of anchors needed for optimal correction is controversial. Methods: We conducted a multicenter, randomized study that included patients undergoing spinal fusion for single thoracic curves between 45° and 65°, the most common form of operatively treated AIS. Of the 211 patients randomized, 108 were assigned to a high-density screw pattern and 103, to a low-density screw pattern. Surgeons were instructed to use ≥1.8 implants per spinal level fused for patients in the high-implant-density group or ≤1.4 implants per spinal level fused for patients in the low-implant-density group. The primary outcome measure was the percent correction of the coronal curve at the 2-year follow-up. The power analysis for this trial required 174 patients to show equivalence, defined as a 95% confidence interval (CI) within a ±10% correction margin with a probability of 90%. Results: In the intention-to-treat analysis, the mean percent correction of the coronal curve was equivalent between the high-density and low-density groups at the 2-year follow-up (67.6% versus 65.7%; difference, −1.9% [95% CI: −6.1%, 2.2%]). In the per-protocol cohorts, the mean percent correction of the coronal curve was also equivalent between the 2 groups at the 2-year follow-up (65.0% versus 66.1%; difference, 1.1% [95% CI: −3.0%, 5.2%]). A total of 6 patients in the low-density group and 5 patients in the high-density group required reoperation (p = 1.0). Conclusions: In the setting of spinal fusion for primary thoracic AIS curves between 45° and 65°, the percent coronal curve correction obtained with use of a low-implant-density construct and that obtained with use of a high-implant-density construct were equivalent. Level of Evidence: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Background: Vertebral body tethering and other non-fusion techniques for the treatment of pediatric idiopathic scoliosis are increasing in popularity. There is limited physician consensus on this topic as the result of a paucity of published data regarding which patients most benefit from non-fusion strategies. Thus, much of the decision-making is left to patients and parents, who must select a treatment based on their goals and values and the information available from health-care providers, the internet, and social media. We sought to understand patient and family preferences regarding the attributes of fusion versus non-fusion surgery that drive these choices. Methods: Patients and families were recruited from 7 pediatric spine centers and were asked to complete a survey-based choice experiment that had been jointly developed with the U.S. Food and Drug Administration (FDA) to evaluate patient preferences. Choices between experimentally designed alternatives were analyzed to estimate the relative importance of outcomes and requirements associated with the choice options (attributes). The attributes included appearance, confidence in the planned correction, spinal motion, device failure, reoperation, and recovery period. The inclusion criteria were (1) an age of 10 to 21 years and (2) a diagnosis of adolescent idiopathic scoliosis in patients who were considering, or who had already undergone, treatment with fusion or non-fusion surgery. Preference weights were estimated from the expected changes in choice given changes in the attributes. Results: A total of 344 respondents (124 patients, 92 parents, and 128 parent/patient dyads) completed the survey. One hundred and seventy-three patients were enrolled prior to surgery, and 171 were enrolled after surgery. Appearance and motion were found to be the most important drivers of choice. For the entire cohort, fusion was preferred over non-fusion. For patients who were considering surgery, the most important attributes were preservation of spinal motion and appearance. Conclusions: Patients and families seeking treatment for idiopathic scoliosis value appearance and preservation of spinal motion and, to a lesser extent, reoperation rates when considering fusion versus non-fusion surgery.